Most isolates of indole positive Proteus (Proteus vulgaris), Enterobacter spp., Morganella morganii, Providencia rettgeri, Serratia spp., and Pseudomonas spp. Bile levels in patients without obstructive biliary disease can reach or exceed serum levels by up to 5 times; however, in patients with obstructive biliary disease, bile levels of Cefazolin for Injection, USP are considerably lower than serum levels (< 1.0 mcg/mL). Cefazolin for Injection, as with all cephalosporins, should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The sodium content is approximately 24 mg (1 mEq)/500 mg of cefazolin sodium or approximately 48 mg (2.1 mEq)/1 gram of cefazolin sodium. Additional medications in the Prescription Medications section by. The color of Cefazolin for Injection, USP solutions may range from pale yellow to yellow without a change in potency. Cefazolin for Injection, USP is a semi-synthetic cephalosporin for parenteral administration. On This Page Indications and Usage Dosage and Administration Dosage Forms and Strengths Contraindications Warnings and Precautions Adverse Reactions/Side Effects Urinary Tract Infections: Due to E. coli, P. mirabilis, Klebsiella species, and some strains of enterobacter and enterococci. Gram-Negative Bacteria:Escherichia coli Proteus mirabilis. Cefazolin for Injection achieves peak urine concentrations of approximately 2,400 mcg/mL and 4,000 mcg/mL respectively following 500 mg and 1 gram intramuscular doses. in adults and pediatric patients 1 month of age and older for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2.1, 2.2, 2.4 and 2.5)]. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Structural Formula: Each vial contains 48 mg of sodium/1 gram of cefazolin sodium. Studies in patients hospitalized with infections indicate that Cefazolin for Injection produces mean peak serum levels approximately equivalent to those seen in normal volunteers. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see PRECAUTIONS, General and DOSAGE AND ADMINISTRATION). Cefazolin achieves peak urine concentrations of approximately 2,400 mcg/mL and 4,000 mcg/mL, respectively following 500-mg and 1-gram intramuscular doses. Controlled studies on adult normal volunteers, receiving 1 gram 4 times a day for 10 days, monitoring CBC, SGOT, SGPT, bilirubin, alkaline phosphatase, BUN, creatinine and urinalysis, indicated no clinically significant changes attributed to Cefazolin for Injection. Skin and Skin Structure Infections: Due to S. aureus (penicillin-sensitive and penicillin-resistant), group A beta-hemolytic streptococci, and other strains of streptococci. https://medlibrary.org/lib/rx/meds/cefazolin-19/. Most isolates of indole positive Proteus (Proteus vulgaris), Enterobacter spp., Morganella morganii, Providencia rettgeri, Serratia spp., and Pseudomonas spp. For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC. Cefazolin is a Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. Cefazolin for Injection is contraindicated in patients who have a history of immediate hypersensitivity reactions (e.g., anaphylaxis, serious skin reactions) to cefazolin or the cephalosporin . In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Endocarditis: Due to S. aureus (penicillin-sensitive and penicillin-resistant) and group A beta-hemolytic streptococci. Antimicrobial ActivityCefazolin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE(1) section: Gram-Positive Bacteria:Staphylococcus aureus Staphylococcus epidermidis Streptococcus agalactiae Streptococcus pneumoniae Streptococcus pyogenes. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. If there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism so that appropriate therapy may be instituted (see DOSAGE AND ADMINISTRATION). The prophylactic administration of Cefazolin for Injection, USP should usually be discontinued within a 24-hour period after the surgical procedure. The Rocephin brand name has been discontinued in the U.S. Sagent Pharmaceuticals product information by RSS, Additional medications in the Prescription Medications section by. Perioperative Prophylaxis: The prophylactic administration of cefazolin for injection preoperatively, intraoperatively, and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated (e.g., vaginal hysterectomy, and cholecystectomy in high-risk patients such as those older than 70 years, with acute cholecystitis, obstructive jaundice, or common duct bile stones). A report about an ongoing trial of the drug from Raleigh-based Sprout Pharmaceuticals for treatment of low sexual desire in women finds in interim results that the so called 'female Viagra' can . Cefazolin for Injection is present in very low concentrations in the milk of nursing mothers. Reconstituted solutions may range in color from pale yellow to yellow without a change in potency. Safety and effectiveness for use in premature infants and neonates have not been established. Within the Prescription Medications section: Use Trial Bulletin to search for clinical trials involving this product: All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent. Cefazolin for injection, USP is supplied in 10 grams Pharmacy Bulk Packages. Pediatric patients with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) Cefazolin for Injection may be used in patients with reduced renal function with the following dosage adjustments: Patients with a creatinine clearance of 55 mL/min. Cefazolin for Injection, USP is a sterile, white to yellowish powder. Methicillin-resistant staphylococci are uniformly resistant to cefazolin. When reconstituted or diluted according to the instructions below, Cefazolin for Injection is stable for 24hours at room temperature or for 10days if stored under refrigeration (5C or 41F). Studies in patients hospitalized with infections indicate that Cefazolin for Injection produces mean peak serum levels approximately equivalent to those seen in normal volunteers. Prolonged use of Cefazolin for Injection may result in the overgrowth of nonsusceptible organisms. Septicemia: Due to S. pneumoniae, S. aureus (penicillin-sensitive and penicillin-resistant), P. mirabilis, E. coli, and Klebsiella species. Cefazolin for Injection is indicated for the treatment of bone and joint infections due to S. aureus in adults and pediatric patients 1 month of age and older for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2.1, 2.2, 2.4 and 2.5)]. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Intraperitoneal administration of Cefazolin for Injection, USP is usually well tolerated. CEFAZOLIN- cefazolininjection, powder, for solutionHospira, Inc. PHARMACY BULK PACKAGE-NOT FOR DIRECT INFUSION. Careful clinical observation of the patient is essential. Privacy Policy | Copyright 2023. Patients with creatinine clearance rates of 10 mL/min. in adults and pediatric patients 1 month of age and older for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2.1, 2.2, 2.4 and 2.5)]. The perioperative use of Cefazolin for Injection, USP may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g., during open-heart surgery and prosthetic arthroplasty). Skin and Skin Structure Infections: Due to S. aureus (penicillin-sensitive and penicillin-resistant), group A beta-hemolytic streptococci , and other strains of streptococci. Intraperitoneal administration of Cefazolin for Injection is usually well tolerated. Most isolates of indole positive Proteus (Proteus vulgaris), Enterobacter spp., Morganella morganii, Providencia rettgeri, Serratia spp., and Pseudomonas spp. Anaphylaxis, eosinophilia, itching, drug fever, skin rash, Stevens-Johnson syndrome. ResistancePredominant mechanisms of bacterial resistance to cephalosporins include the presence of extended-spectrum beta-lactamases and enzymatic hydrolysis. Cefazolin for Injection is excreted unchanged in the urine. Packaging NDC 0143-9261-10 Intraperitoneal administration of Cefazolin for Injection is usually well tolerated. Studies have shown that following intravenous administration of Cefazolin for Injection to normal volunteers, mean serum concentrations peaked at approximately 185 mcg/mL and were approximately 4 mcg/mL at 8 hours for a 1 gram dose. The perioperative use of cefazolin for injection may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g., during open-heart surgery and prosthetic arthroplasty). This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional. Cefazolin for Injection is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of Cefazolin for Injection in the subsequent prevention of rheumatic fever are not available at present. If there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism so that appropriate therapy may be instituted (see DOSAGE AND ADMINISTRATION). ), 60 percent of the normal daily dose given in equally divided doses every 12 hours should be sufficient. 3 mL The order is for Cefazolin 0.5 g IM. Patients should be counseled that antibacterial drugs including Cefazolin for Injection, should only be used to treat bacterial infections. This site complies with the HONcode standard for trustworthy health information: verify here. Cefazolin for Injection is indicated for the treatment of endocarditis due to S. aureus (methicillin-susceptible) and Group A beta-hemolytic streptococci in adults and pediatric patients 1 month of age and older for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2.1, 2.2, 2.4 and 2.5)]. In pediatric patients with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min. Studies of cord blood show prompt transfer of Cefazolin for Injection across the placenta. In surgery where the occurrence of infection may be particularly devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic administration of Cefazolin for Injection, USP may be continued for 3 to 5 days following the completion of surgery. Toronto, ON M9W 0C8 . The current match involves a Texas lawsuit . In the first 6 hours approximately 60% of the drug is excreted in the urine and this increases to 70% to 80% within 24 hours. ), cefazolin produced mean serum levels of approximately 10 and 30 mcg/mL after 24 hours instillation of a dialyzing solution containing 50 mg/L and 150 mg/L, respectively. All dosage recommendations apply after an initial loading dose. Perioperative Prophylaxis: The prophylactic administration of Cefazolin for Injection, USP preoperatively, intraoperatively, and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated (e.g., vaginal hysterectomy, and cholecystectomy in high-risk patients such as those older than 70 years, with acute cholecystitis, obstructive jaundice, or common duct bile stones). CLINICAL PHARMACOLOGY Within the Prescription Medications section: Use Trial Bulletin to search for clinical trials involving this product: All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent. To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are: It is important that (1) the preoperative dose be given just (1/2 to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) Cefazolin for Injection be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms. What is NDC 44567-120-25? Probenecid may decrease renal tubular secretion of cephalosporins when used concurrently, resulting in increased and more prolonged cephalosporin blood levels. What is NDC 25021-101-67? Cefazolin for Injection, USP is a sterile white or off-white powder or crystalline powder containing Cefazolin Sodium USP supplied in vials equivalent to 1 gram or 2 grams of cefazolin. Cefazolin for injection is indicated in the treatment of the following infections due to susceptible organisms: Respiratory Tract Infections: Due to S. pneumoniae, Klebsiella species, H. influenzae, S. aureus (penicillin-sensitive and penicillin-resistant), and group A beta-hemolytic streptococci. The molecular formula is C14H13N8NaO4S3 and molecular weight is 476.49. The table below shows the 11-digit code conversion: In synovial fluid, the level of Cefazolin for Injection becomes comparable to that reached in serum at about 4 hours after drug administration. In the first 6 hours approximately 60% of the drug is excreted in the urine and this increases to 70% to 80% within 24 hours. Cefazolin for Injection, USP is indicated in the treatment of the following serious infections due to susceptible organisms: Respiratory Tract Infections: Due to S. pneumoniae, Klebsiella species, H. influenzae, S. aureus (penicillin-sensitive and penicillin-resistant), and group A beta-hemolytic streptococci. A false positive reaction for glucose in the urine may occur with Benedict's solution, Fehling's solution or with CLINITEST tablets, but not with enzyme-based tests such as CLINISTIX. Intraperitoneal administration of cefazolin for injection is usually well tolerated. General Injectables and Vaccines, Inc. product information by RSS, Additional medications in the Prescription Medications section by. Cefazolin for Injection achieves peak urine concentrations of approximately 2,400mcg/mL and 4,000mcg/mL respectively following 500-mg and 1-gram intramuscular doses. are resistant to cefazolin. It is the sodium salt of (6R,7R)-3-{[(5-methyl-1,3,4-thiadiazol-2-yl)thio] methyl}-8-oxo-7-[2-(1H-tetrazol-1-yl)acetamido]-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid. SHAKE WELL. Cefazolin for Injection is indicated for the treatment of septicemia due to S. pneumoniae, S. aureus (methicillin-susceptible), P. mirabilis, E. coli, and Klebsiella species in adults and pediatric patients 1 month of age and older for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2.1, 2.2, 2.4 and 2.5)]. This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional. The serum half-life for Cefazolin for Injection is approximately 1.8 hours following intravenous administration. The sodium content is 48 mg (2.1 mEq) per 1 gram of cefazolin sodium. Cefazolin for Injection is indicated for the treatment of skin and skin structure infections due to S. aureus (methicillin-susceptible), Group A beta-hemolytic streptococci, and Streptococcus species (spp.) Last updated on May 1, 2023. Cefazolin for Injection is present in very low concentrations in the milk of nursing mothers. Package insert / product label Generic name: ceftriaxone sodium Dosage form: injection, powder, for solution Drug class: Third generation cephalosporins Medically reviewed by Drugs.com. Studies of cord blood show prompt transfer of cefazolin across the placenta. Skin and Skin Structure Infections: Due to S. aureus (penicillin-sensitive and penicillin-resistant), group A beta-hemolytic streptococci , and other strains of streptococci. Cefazolin for Injection, USP is white to off-white crystalline powder, supplied in vials equivalent to 500 mg or 1 gram of cefazolin. Skin and Skin Structure Infections: Due to S. aureus (penicillin-sensitive and penicillin-resistant), group A beta-hemolytic streptococci, and other strains of streptococci. A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. 7 February 2022 Evaluation commenced 30 April 2021 Decision date 3 February 2022 Approval time 121 (255 working days) Active ingredients cefazolin sodium Registration type New generic medicine Indication CEFAZOLIN-AFT (powder for injection) is indicated for treatment of the following serious infections due to susceptible organisms: To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefazolin for Injection, USP and other antibacterial drugs, Cefazolin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. In synovial fluid, the level of cefazolin becomes comparable to that reached in serum at about 4 hours after drug administration. Fresenius Kabi Canada Ltd. 165 Galaxy Blvd, Suite 100 . Cefazolin for Injection is indicated for the treatment of biliary tract infections due to E. coli, various isolates of Streptococcus spp., P. mirabilis, Klebsiella spp., and S. aureus (methicillin-susceptible) in adults and pediatric patients 1 month of age and older for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2.1, 2.2, 2.4 and 2.5)]. Gram-Negative Bacteria:Escherichia coli Proteus mirabilis. are resistant to cefazolin. (mL) needed with dilution of 125mg/mL, Vol. Cefazolin is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. Bone and Joint Infections: Due to S. aureus. This site complies with the HONcode standard for trustworthy health information: verify here. Cefazolin for Injection USP and Dextrose Injection USP is a sterile, nonpyrogenic,single use, packaged combination of Cefazolin Sodium USP (lyophilized) and sterileisoosmotic diluent in the. Structural Formula: Each vial contains 48 mg (2 mEq) of sodium/1 gram of cefazolin sodium. The perioperative use of Cefazolin for Injection may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g., during open-heart surgery and prosthetic arthroplasty). The NDC Packaged Code 25021-101-67 is assigned to a package of 25 vial in 1 carton / 3 ml in 1 vial of Cefazolin, a human prescription drug labeled by Sagent Pharmaceuticals. The Romance Retreat will see a group of single parents looking . The product's dosage form is injection, powder, for solution and is administered via intramuscular; intravenous form . On This Page Indications and Usage Dosage and Administration Dosage Forms and Strengths Last updated on Jul 22, 2022. In synovial fluid, the level of Cefazolin for Injection, USP becomes comparable to that reached in serum at about 4 hours after drug administration. In the first 6 hours approximately 60% of the drug is excreted in the urine and this increases to 70% to 80% within 24 hours. In the first 6 hours approximately 60% of the drug is excreted in the urine and this increases to 70% to 80% within 24 hours. After intramuscular administration of Cefazolin for Injection, USP to normal volunteers, the mean serum concentrations were 37 mcg/mL at 1 hour and 3 mcg/mL at 8 hours following a 500-mg dose, and 64 mcg/mL at 1 hour and 7 mcg/mL at 8 hours following a 1-gram dose. This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional. Methicillin-resistant staphylococci are uniformly resistant to cefazolin. Patients with creatinine clearance rates of 11 to 34 mL/min. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefazolin for Injection, USP is a sterile white to cream powder supplied in vials. Intramuscular, Intravenous . Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see WARNINGS). For healthcare professionals. In patients undergoing peritoneal dialysis (2 L/hr. Perioperative Prophylaxis: The prophylactic administration of Cefazolin for Injection, USP preoperatively, intraoperatively, and postoperatively may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures which are classified as contaminated or potentially contaminated (e.g., vaginal hysterectomy, and cholecystectomy in high-risk patients such as those older than 70 years, with acute cholecystitis, obstructive jaundice, or common duct bile stones). 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